Compositions having absorbable materials, methods, and applicators for sealing injuries

Abstract

Disclosed are solid and frozen haemostatic materials utilizing an absorbable scaffolding material and consisting essentially of a fibrinogen component and a fibrinogen activator. Also disclosed are methods of treating internal wounded tissue in a mammal by applying one or more of these haemostatic materials and dressings, particularly for the treatment of injured tissue via endoscopic or minimally-invasive surgical techniques.

1 . A haemostatic material cast as a single piece comprising an absorbable scaffolding, a fibrinogen component, a fibrinogen activator, and water, wherein said haemostatic material is made by combining said fibrinogen component, fibrinogen activator and water at 4° C.+/−2° C., absorbing said fibrinogen component, fibrinogen activator and water into said absorbable scaffolding, freezing said resulting scaffolding, and lyophilizing. 
     
     
         2 . The haemostatic material of  claim 1 , further comprising one or more of the following: at least one binding agent, at least one filler; at least one solubilizing agent; at least one foaming agent; and at least one release agent. 
     
     
         3 . The haemostatic material of  claim 1 , further comprising at least one therapeutic supplement selected from the group consisting of antibiotics, anticoagulants, steroids, cardiovascular drugs, growth factors, antibodies (poly and mono), chemoattractants, anesthetics, antiproliferatives/antitumor agents, antivirals, cytokines, colony stimulating factors, antifungals, antiparasitics, antiinflammatories, antiseptics, hormones, vitamins, glycoproteins, fibronectin, peptides, proteins, carbohydrates, proteoglycans, antiangiogenins, antigens, nucleotides, lipids, liposomes, fibrinolysis inhibitors, procoagulants, anticoagulants, vascular constrictors and gene therapy reagents. 
     
     
         4 . A device for treating wounded internal tissue in a mammal comprising:
 (a) an applicator;   (b) a haemostatically effective amount of a haemostatic material made by combining a fibrinogen component and a fibrinogen activator in an aqueous solution at a temperature of between 0° C.-12° C.; and   (c) wherein said applicator further comprises an absorbable medium disposed of on one end of said applicator, wherein said absorbable medium is placed into said aqueous solution to absorb said aqueous fibrinogen component and fibrinogen activator, and subsequently frozen and lyophilized under conditions providing less than about 5% γ-γ dimer.   
     
     
         5 . The device according to  claim 4 , wherein said applicator comprises a rod, plunger or tamper. 
     
     
         6 . The device according to  claim 4 , wherein said applicator comprises a guide wire. 
     
     
         7 . The device according to  claim 4 , wherein said applicator further comprises a substantially rigid sheath. 
     
     
         8 . The device according to  claim 7 , wherein said substantially rigid sheath is a cylinder, syringe, cannula or endoscopic tube. 
     
     
         9 . The device according to  claim 4 , wherein said applicator further comprises a substantially flexible sheath. 
     
     
         10 . The device according to  claim 9 , wherein said substantially flexible sheath is a cylinder, catheter or endoscopic tube. 
     
     
         11 . The device according to  claim 4 , wherein said haemostatic material is affixed to a terminal portion of said rod, plunger or tamper. 
     
     
         12 . The device according to  claim 9 , wherein substantially all of said haemostatic material is contained within said substantially flexible sheath. 
     
     
         13 . The haemostatic material of  claim 1 , wherein said haemostatic material includes at least one support layer. 
     
     
         14 . The haemostatic material of  claim 13 , wherein said support layer comprises a resorbable material. 
     
     
         15 . The haemostatic material of  claim 13 , wherein said support layer comprises a nonresorbable material. 
     
     
         16 . The haemostatic material of  claim 15 , wherein said non-resorbable material is selected from the group consisting of silicone polymers, carbohydrate polymers, paper, gauze, plastics, non-resorbable suture materials, woven non-resorbable suture materials, latexes and suitable derivatives of thereof. 
     
     
         17 . The haemostatic Material of  claim 13 , further comprising at least one physiologically acceptable adhesive between said haemostatic material and said support layer. 
     
     
         18 . The haemostatic material of  claim 14 , wherein said resorbable material is selected from the group consisting of proteinaceous materials, carbohydrate substances, resorbable suture materials, woven resorbable suture materials, tufted materials, felted materials and spongy materials. 
     
     
         19 . The haemostatic material of  claim 18 , wherein said proteinaceous material is at least one substance selected from the group consisting of keratin, silk, fibrin, collagen, gelatin and suitable derivatives thereof. 
     
     
         20 . The haemostatic material of  claim 18 , wherein said carbohydrate substance is selected from the group consisting of alginic acid and salts thereof, chitin, chitosan, cellulose, n-acetyl glucosamine, proteoglycans, glycolic acid polymers, lactic acid polymers, glycolic acid/lactic acid co-polymers, suitable derivatives thereof and mixtures of two or more thereof. 
     
     
         21 - 51 . (canceled)